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510(k) K850711

Device
Inhalation Therapy Nebulizer Device
Applicant
MED USA
510(k) number
K850711
Product code
KFZ
Decision
Substantially Equivalent (SESE)
Decision date
1985-06-05
Date received
1985-02-22
Regulation
868.5460
Classification name
Humidifier, Non-Direct Patient Interface (Home-Use)
Medical specialty
Anesthesiology
Review panel
Anesthesiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES R RUNDELL
Address
319 Waverley Oaks Rd. Waltham MA US 02154 02154

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KFZ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K950116THERASTEAM PERSONAL STEAM INHALERKaz, Inc.1995-02-10
K915603VIROTHERM HUMIDIFIERVirotherm Laboratory1992-10-22
K894734RHINOTHERM ULTRA 2Twinmed Products, Inc.1990-02-16
K871661WH150 ROOM HUMIDIFIERAssociated Mills, Inc.1987-06-15
K871189SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380Sunbeam Appliance Service Co.1987-05-08
K862919TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIERTranspirator Technologics, Inc.1986-11-07
K862171MP-500 ELECTRONIC NEBULIZERThe Timeter Group1986-07-14
K862042SH20, SH30 & SH50 ULTRASONIC HUMIDIFIERAssociated Mills, Inc.1986-06-05
K851220SUNBEAM EVAPORATIVE HUMIDIFIER 663 & 664Northern Electric Co. Div. of Sunbeam Corp.1985-09-17
K852283THERMIX INC. NASOTHERM II PERSONAL STEAM MACHINEThermix, Inc.1985-07-30
K842275ULTRASONIC COOL SPRAY HUMIDIFIERSunbeam Corp.1984-08-14
K840118RHINOTHERMAscot Pharmaceuticals, Inc.1984-04-13
K831646SONIC MIST ULTRASONIC HUMIDIFIERDouglas Products1983-07-12
K830896HUMIDIFIER, WITH OR WITHOUT ADAPTERAirlife, Inc.1983-04-18
K811161HUMIDIFIER W/ OR W/OUT ADAPTORAirlife, Inc.1981-06-24